Kornimate/medical-research-clean huggingface dataset:
scale-up of prevention and management of alcohol use disorders and comorbid depression in latin america

Conditions: Alcohol Use Disorder

Summary: a quasi-experimental study will compare primary health care-based prevention and management of alcohol use disorder, operationalized by heavy drinking, in three intervention cities from colombia, mexico and peru with three comparator cities from the same countries. in the implementation cities, primary health care units (phcus) will receive training embedded within ongoing supportive municipal action over an 18-month implementation period. in the comparator cities, practice as usual will continue at both municipal and phcu levels. the primary outcome will be the proportion of consulting adult patients intervened with (screened and advice given to screen positives).


Eligibility criteria:
inclusion criteria: * any fully trained medical practitioner, nurse or practice assistant * non-temporary employment contract * working in the selected primary health care centre * involved in medical and/or preventive care exclusion criteria: * not a fully trained medical practitioner, nurse or practice assistant * having a temporary employment contract * not working in the selected primary health care centre * not involved in medical and/or preventive care

Keywords: heavy drinking primary health care training community
metformin plus neoadjuvant chemotherapy in breast cancer

Conditions: Locally Advanced Malignant Neoplasm

Summary: background obesity and overweight are well known risk factors for breast cancer and also are associated with higher recurrence and mortality rates. main goal of this study is to evaluate the efficacy of metformin plus chemotherapy in terms of pathologic complete response in comparison with placebo plus the same chemotherapy regimen design: randomized, double blind, clinical trial. this study will be performed at national cancer institute of mexico city, at breast cancer unit. patients with er+ or pr+, her2 negative, breast cancer are candidates to participate. after completion of chemotherapy all patients will have a breast surgery to assess pathologic response. complete pathologic response is defined as the abscence of malignant cells in breast tissue and lymph nodes. the presence of dcis is considered as pcr

definitions luminal a: tumors er + pr + her2 negative and ki67 \ 15% complete pathologic response is defined as the abscence of malignant cells in breast tissue and lymph nodes. the presence of dcis is considered as pcr

Eligibility criteria:
inclusion criteria: * women older than 18 years old and younger than 70 years old * invasive breast cancer confirmed by core biopsy, any histology * tumor ≥2 cm and/or lymph node positive (proven by fna)(t2-4b, n0-3, m0) * must have er/pr positive and her2 negative * must have full staging and extent disease and clinically and radiographically tumor measure * without previous treatment for breast cancer (including surgery, hormonotherapy or chemotherapy) * normal liver, kidney and blood tests * performance status ecog 0-2 o karnofsky ≥70% * fasten glucose levels \<125 mg/dl * signed consent exclusion criteria: * previous use of metformin for any indication * presence of diabetes mellitus

Keywords: locally advanced breast cancer neoadjuvant chemotherapy metformin pathologic complete response
dose ranging study of recombinant human insulin-like growth factor i in children with hyperinsulinism

Conditions: Hyperinsulinism

Summary: objectives: i. determine the dose of recombinant human insulin-like growth factor i that minimizes or decreases the need for exogenous glucose support without causing hypoglycemia.

protocol outline: this is a dose escalation study. patients receive an escalating dose of recombinant human insulin-like growth factor i (igf-i). igf-i is given subcutaneously twice a day. the dose of igf-i is increased each day for 4 days. glucose is administered intravenously, when necessary, to prevent hypoglycemia. following the study treatment patients resume prior medication and may undergo surgery. completion date provided represents the completion date of the grant per oopd records

Eligibility criteria:
protocol entry criteria: --disease characteristics-- * diagnosis of hyperinsulinism (i.e., evidence of fasting hypoglycemia with inadequate suppression of insulin, normal pituitary and adrenal function, and increased insulin action) * intractable hypoglycemia (i.e., persistent iv glucose requirement for maintaining glucose levels greater than 60 mg/dl) * failed standard treatment regimen of diazoxide, octreotide, and frequent feedings to control hypoglycemia * no other major medical problems

Keywords: endocrine disorders hyperinsulinism rare disease
fluorescence versus intraoperative cholangiography in the visualization of biliary tree anatomy

Conditions: Cholelithiasis; Gallbladder Polyps

Summary: the burden of iatrogenic bile duct injury (bdi), the most feared complication of laparoscopic cholecystectomy (lc), is extremely high and the repercussions on the patient's outcomes may be severe ranging from intraoperative repair to liver transplant or patient's death. different techniques have been proposed to prevent bdi. our hypothesis is that a fluorescence-based imaging would allow visualization of the biliary tree anatomy as good as with the intraoperative cholangiogram with several main advantages: 1. ease of use 2. lack of invasiveness 3. absence of ionizing radiation to the patient and the operating staff 4. performed prior to any dissection (prior to "critical view of safety") capacity of enhanced-reality based on virtual cholangiography (computer treatment of mri images) to guide biliary tree anatomy visualization will be also evaluated in this study. the study requires a 2-month patient participation.


Eligibility criteria:
inclusion criteria: * man or woman \> 18 years old * symptomatic gallbladder lithiasis or gallbladder polyps * clinical, biological ou medical imaging history leading to suspicion of gallstones migration * absence of contra-indication to anesthesia and cholecystectomy procedure * ability to understand the study related information and to provide written informed consent * registered with the french social security regime non inclusion criteria: * inability to give informed consent * acute cholecystitis * contraindications to mri exam (claustrophobia, implantable devices) * potential risk of allergic reactions to iodine-containing contrast agents, to indocyanine green or other fluorescent compounds * pregnancy or breast-feeding * exclusion period from other clinical trial * forfeit freedom from an administrative or legal obligation * under guardianship

Keywords: cholelithiasis gallbladder polyps fluorescence indocyanine green (icg) intraoperative cholangiography (ioc) da vinci surgical system
studying the incidence of erectile dysfunction in patients complaining of congenital penile curvature

Conditions: To Assess Erectile Function in Patients Complaining of Congenital Penile Curvature

Summary: patients complaining of congenital penile curvature were subject to penile duplex study to assess their curvature. their penile duplex data including peak systolic velocity, end diastolic velocity and resistivity index were recorded as well as their assessing the degree of curvature and the quality of their erection using the erection hardness grading scale.


Eligibility criteria:
inclusion criteria: * complaining of congenital curvature exclusion criteria: -

Keywords: congenital penile curvature, erectile dysfunction
exercise cmr in (p)lf-lg as

Conditions: Aortic Stenosis, Severe

Summary: patient with paradoxical or conventional low-flow low-gradient aortic stenosis on echocardiographic assessment will undergo physiological exercise-stress cmr in addition to guideline recommended surveys prior to tavr.


Eligibility criteria:
inclusion criteria: * paradoxical or conventional severe low-flow low-gradient aortic stenosis exclusion criteria: * cmr incapable device * unable to undergo 40 min scan (can not lie flat, claustrophobia) * renal insufficiency (egfr \<30 ml/min/1.73m²) * allergy against contrast agent * unable to exercise in supine position
evaluation of the safety and efficacy of bilateral subthalamic nucleus (snt) radiosurgery in idiopathic severe parkinson's disease fulfilling inclusion criteria for stn deep brain stimulation and presenting with a contraindication to intracerebral electrode implantation.

Conditions: Parkinson's Disease; With Inclusion Criteria for STN Deep Brain Stimulation; Presenting a Contraindication to Intracerebral Electrode Implantati

Summary: the goal of our trial is to evaluate the tolerance and efficacy of the stn radiosurgery in parkinsonian patients presenting with the inclusion criteria for the stn stimulation but presenting also with clear contraindications to the implantation of the deep brain electrodes.

subthalamic nucleus (snt) deep brain stimulation (dbs) is the reference treatment for severe drug resistant parkinson's disease, responsible to dopaminergic therapy, to the state of complication. the efficacy of this therapeutic approach has transformed the functional prognosis of these patients. unfortunately, those of the patients presenting with contraindications for anaesthesia or electrode implantation are excluded of these therapeutic hope. gamma knife radiosurgery is a neurosurgical procedure going to operate in the brain of the patients without opening the skull without infection or bleeding risk. gamma knife radiosurgical treatment will be done in two separate times (gk1 and gk2). treatment of the second side (gk2) will be done at least 12 months after the treatment of the first side (gk1), in the same methodology as the first treatment. the major risk of onset of acute ballism although low is planned to be managed by the standard protocol by the recruiting team involved in the trial.

Eligibility criteria:
inclusion criteria: * patients presenting with contraindications for anaesthesia or electrode implantation exclusion criteria: * contraindications for a surgical treatment * pregnant or breast-feeding women

Keywords: parkinson contraindication to intracerebral electrode implantation gamma knife radiosurgery
study of two doses of abx464 in participants with moderate to severe rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: this phase iia study aims at investigating the safety and tolerability of 2 dose-levels of abx464 administered daily in combination with methotrexate (mtx) in patients with moderate to severe active rheumatoid arthritis (ra) who had an inadequate response to mtx or/and to one or more anti- tumor necrosis factor alpha (tnfα) therapies.

this is a randomized, double-blind, placebo-controlled, multicenter study. the study will consist of 3 phases: a screening phase, a treatment phase, and a follow-up phase. approximately 60 participants with active rheumatoid arthritis will be randomly assigned to receive placebo, 50mg abx464 or 100mg abx464 during the treatment phase. the maximum period of active treatment will be 12 weeks. the maximum duration of study participation will be 17 weeks. participant safety will be monitored throughout the study. in addition, several experimental and clinical endpoints will be assessed to obtain information on preliminary efficacy.

Eligibility criteria:
inclusion criteria: * patient with a confirmed and documented diagnosis of adult-onset rheumatoid arthritis, for at least 12 weeks, according to the revised 2010 american college of rheumatology- european league against rheumatism (acr-eular) classification criteria, including at least one positive criteria among the following: rheumatoid factor (rf), anti-citrullinated peptide antibody (acpa) or bone erosion; * swollen joint count (sjc) of ≥ 4 (28-joint count) and tender joint count (tjc) ≥4 (28-joint count) at screening; * patient with a moderate to severe disease activity score disease activity score (28 joints) c-reactive protein \[das28 crp\] ≥ 3.2 and c-reactive protein (crp) ≥ 5 mg/l (≥ 4.76 nmol)/l) at screening; * patient who had an inadequate response (ir), or failed either methotrexate (mtx) or/and anti- tumor necrosis factor alpha (tnfα) therapy (both administered for at least 12 weeks before ir) or were intolerant to anti- tnfα therapy. exclusion criteria: * patient with a known positive anti-double stranded deoxyribonucleic acid (dna \[anti-dsdna\]) and confirmed diagnosis of systemic lupus erythematosus (sle); * patient with known active infections at screening such as cytomegalovirus (cmv), herpes virus and/or recent infectious hospitalization; * acute, chronic or history of clinically relevant pulmonary, cardiovascular, hepatic, pancreatic or renal functional abnormality, encephalopathy, neuropathy or unstable central nervous system (cns) pathology such as seizure disorder, angina or cardiac arrhythmias, active malignancy or any other clinically significant medical problems as determined by physical examination and/or laboratory screening tests and/or medical history; * acute, chronic or history of immunodeficiency or other autoimmune disease; * patient previously treated with any non-anti-tnf biological disease-modifying antirheumatic drugs (bdmards), and targeted dmards (tdmards) prior to baseline.
efficacy study of tace to treat hepatocellular carcinoma after operation

Conditions: Carcinoma, Hepatocellular; Neoplastic Cells, Circulating

Summary: this study is designed to prospectively evaluate whether post-hepatectomy adjuvant transcatheter arterial chemoembolization (tace) is effective in reducing early recurrence in hcc patients with preoperative ctc ≥2.

hepatocellular carcinoma (hcc) is one of the most prevalent malignancies worldwide, and associated morbidity and mortality rates have escalated in recent years. despite improvements in surveillance and clinical treatment strategies, the prognosis of hcc remains very poor due to high incidence of recurrence and metastasis. recent clinical studies have provided evidence that circulating tumor cell (ctc) may directly participate in the metastasis cascade in various types of malignancies. the investigators previous data indicated that hcc patients with preoperative ctc levels ≥2 suffered significantly earlier recurrence (within 1 year) than patients with lower levels. however, the benefits of postoperative adjuvant therapies in preventing early recurrence in patients with preoperative ctc ≥2 remain to be elucidated. transarterial chemoembolisation (tace) is an effective palliative treatment for hcc. the investigators design a randomised controlled trial evaluating the efficacy of using tace after hepatectomy to reduce early recurrence rates in hcc patients with preoperative ctc level ≥2.

Eligibility criteria:
inclusion criteria: * hcc patients received curative hepatectomy with negative resection margin * age from 18 to 75 * child-pugh class a * asa class i to ii * ecog performance status grade 0 or 1 * preoperative ctc level ≥2 per 7.5 ml peripheral blood * no residual tumor revealed by hepatic arterial angiography 4-6 weeks after hepatectomy exclusion criteria: * patients diagnosed with other types of malignancies besides hcc * patients receiving concomitant local ablation or previous tace * main portal vein tumor thrombus extraction during hepatectomy * hepatic arterial angiography before adjuvant tace treatment reveals residual tumors. * presence of extra-hepatic or lymphatic metastasis * impaired liver function with either clinically detected ascites, hepatic encephalopathy, serum albumin \ 50micromol/l * renal impairment with creatinine \> 200micromol/l * severe concurrent medical illness persisting \> 6 weeks after hepatectomy * history of other cancer * hepatic artery anomaly making tace not possible * allergy to 5-fluorouracil, epirubicin or lipiodol * pregnant woman * informed consent not available

Keywords: circulating tumor cells hepatoectomy tace prognosis relapse chemoembolization, therapeutic
assisted exercise in prematurity; effects and mechanisms

Conditions: Growth; Development

Summary: briefly our study is looking at the effects of 4 weeks of assisted exercise on the body composition and neurological/behavioral development of healthy growing premature infants enrolled between the ages of 30-33 weeks. it is a blinded study where the active group gets the exercise intervention and the control group is cuddled for the same amount of time -approximately 20 minutes. we get baseline data using muscle ultrasound, bone speed of sound and dexa. we also get baseline blood samples to look at inflammatory mediators and growth hormone. video of each subject is recorded an hour at two time points during the study to assess the babies for spontaneous activity. nutritional intake information is collected daily and in the 4th week of the study assessments made for total energy expenditure using doubly labeled water. at this point in the study we repeat the ultrasounds and dexa for comparison. finally in the period just before discharge we do a complex neurological exam using the brazelton nbas assessment.


Eligibility criteria:
inclusion criteria: * preterm infants born at post menstrual ages of 23-33 weeks gestation enrollment occurs at post menstrual age of 30 to 35 weeks.if their projected stay based on standard clinical criteria is four weeks after enrollment * enrollment occurs at post menstrual age of 30 up to 35 weeks, if their projected stay based on standard clinical criteria is 4 weeks after enrollment. * birth weight appropriate for gestational age (aga) using current cdc growth charts. aga is defined as plus or minus 2 standard deviations above the mean or above the third percentile. * tolerating full enteral feeds at greater than or equal to 100kcal/kg/day exclusion criteria: * evidence of chromosomal or other major genetic abnormalities * existence of current diseases or syndromes including: central nervous system or other neurological abnormalities chronic lung disease of prematurity requiring chronic use of corticosteroids, musculoskeletal diseases * positive infant toxicology screen(urine) for drugs or alcohol * both parents are under the age of 18 years * babies with tracheostomy * babies receiving ventilator assistance with breathing * babies receiving iv fluids

Keywords: premature infant, body composition, total energy expenditure inflammatory growth mediators
serum markers of ischemia reperfusion injury in liver transplant patients

Conditions: Liver Transplant

Summary: this is an observational study examining serum markers in patients who are undergoing either a cadaveric liver transplant or a living related liver transplant.

the departments of anesthesiology are conducting an observational trial of markers in the serum of patients who are undergoing liver transplantation surgery. this study will utilize the biological markers, trimethylamine-n-oxide (tmao), ngal, and cystatin-c, sensitive markers of renal medullary injury in the blood and allantoin, a marker of oxidative stress as indicators of renal injury in a kidney during liver transplants. it is hypothesized that: (1) these markers are less pronounced in living donor liver transplant recipient patients than in cadaveric liver transplant recipients, and (2) these markers are less pronounced in cadaveric liver transplant recipients in which a "piggy-back" technique was used versus recipients in which a total venous occlusion technique was used. this study will be done in a multi-center format, along with researchers at ucsf

Eligibility criteria:
inclusion criteria: * american society of anesthesiologists (asa) class i-v. * patient is undergoing elective liver transplant surgery. * patient is an adult, 18 years old or older. exclusion criteria: * patients \< 18 years of age * patients who are pregnant

Keywords: liver transplant tmao ngal cystatin-c ischemia reperfusion injury liver transplant ltx allantion
study to evaluate the effect of ha44 gel on the electrocardiogram in healthy volunteers

Conditions: Pediculosis

Summary: the purpose of this study is to evaluate the effect of ha44 gel on the electrocardiogram in healthy volunteers.

this study was a randomized, double-blind, placebo- and active-controlled, crossover study that evaluated the potential of abametapir to prolong cardiac repolarization in healthy adult subjects (total of 57 subjects).

Eligibility criteria:
inclusion criteria: * healthy male or female subject, 18 to 50 years of age, inclusive, at least 45 kg and has a body mass index (bmi) of 18 to 33 kg/m2, * female subjects of childbearing potential must not be pregnant and not lactating or prepared to practice highly effective birth control methods * the subject has normal 12-lead ecg results or, if abnormal, the abnormality is not clinically significant (as determined by the investigator). exclusion criteria: * has evidence of cardiac conduction abnormalities * history of unexplained syncope, cardiac arrest, unexplained cardiac arrhythmia or torsade de pointes, structural heart disease, or family history of long qt syndrome (suggested by sudden death of a close relative due to cardiac causes at a young age * potassium, calcium, or magnesium levels that are below the clinical laboratory's lower limit of normal * laboratory test results at screening are \>2 x the upper limit of normal (uln) for alanine aminotransferase (alt) or aspartate aminotransferase (ast), \>1.5 x uln for bilirubin, or \>1.5 x uln for creatinine * history or evidence of any clinically significant (as determined by the investigator) cardiovascular, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or other major disease or malignancy (excluding non-melanoma skin cancer) * febrile illness or symptomatic viral, bacterial (including upper respiratory infection), or fungal (non-cutaneous) infection within 1 week before clinic admission * supine mean systolic blood pressure \ 140 mmhg and a mean diastolic blood pressure \ 90 mmhg * positive for hiv or hepatitis c antibody or hepatitis b antigen (hbsag)
bap1 testing in instance choroidal nevi or uveal melanoma

Conditions: Choroidal Nevi, Uveal Melanoma

Summary: the bap1 trial will examine the blood of patients diagnosed with choroidal nevi or uveal melanoma for a germline bap1 mutation and other genetic markers associated with developing malignancy as well as additional sequencing of the uveal melanoma genome.

a germline bap1 mutation predisposes a person to developing uveal melanoma and other cancers. if a mutation is discovered, it changes the potential approach to managing the nevus. in the presence of a known genomic change associated with aggressive disease, closer follow up and more aggressive treatment could preserve the patient's vision and prevent micrometastatic spread. this new screening technique will be able to extend the length and quality of life of patients with more frequent targeted cancer screens.

Eligibility criteria:
inclusion criteria: any person with choroidal nevi * willingness to provide signed informed consent * age \> 18 years * diagnosis of choroidal nevi or uveal melanoma threre are no exclusionary criteria for this study.

Keywords: nevus choroidal melanoma bap1 mutation